FDA Recall Famotidine

The last Recall Enforcement Report for Famotidine with NDC 55111-396 was initiated on 10-03-2017 as a Class III recall due to failed impurities/degradation specifications: famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval. The latest recall number for this product is D-0009-2018 and the recall is currently terminated as of 03-15-2019 .

Recall Number D-0009-2018

Field Name	Field Value
Event ID	78220 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0009-2018 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India
Reason For Recall	Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	569376 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	10-18-2017
Recall Initiation Date	10-03-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-15-2019 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Dr. Reddy's Laboratories, Inc.
Code Info	Lot #: a) 79C408882B, 79C408884C, 79C408886B, Exp 10/17; 79C501523B, Exp 01/18; 79C501524B, Exp 01/18; 79C502318B, Exp 3/18; b) 79C408885B, 79C408886A, Exp 10/17; 79C500967, 79C501523C, 79C501525A, 79C501525B, 79C501525C, 79C501526B, Exp 01/18; 79C502317A, Exp 3/18; 79C504087B, 79C504088A, Exp 5/18; 79C505926A, Exp 7/18. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	55111-118-30; 55111-118-40; 55111-118-60; 55111-118-90; 55111-118-04; 55111-118-18; 55111-118-24; 55111-118-35; 55111-118-81; 55111-118-79; 55111-118-12; 55111-396-35; 55111-396-50; 55111-396-65; 55111-396-90; 55111-396-01; 55111-396-44; 55111-396-13; 55111-396-32; 55111-396-08; 55111-396-16; 49035-118-30; 49035-118-90; 49035-118-12
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
	View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.